GILENYA: 1,672 Adverse Event Reports & Safety Profile
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1,672
Total FAERS Reports
42 (2.5%)
Deaths Reported
419
Hospitalizations
1,672
As Primary/Secondary Suspect
36
Life-Threatening
49
Disabilities
First Report: 20071007 · Latest Report: 20140623
What Are the Most Common GILENYA Side Effects?
#1 Most Reported
Fatigue
208 reports (12.4%)
#2 Most Reported
Multiple sclerosis relapse
161 reports (9.6%)
#3 Most Reported
Headache
154 reports (9.2%)
All GILENYA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Fatigue | 208 | 12.4% | 0 | 34 |
| Multiple sclerosis relapse | 161 | 9.6% | 6 | 79 |
| Headache | 154 | 9.2% | 0 | 34 |
| Dizziness | 119 | 7.1% | 1 | 38 |
| Central nervous system lesion | 107 | 6.4% | 4 | 30 |
| Gait disturbance | 93 | 5.6% | 3 | 27 |
| Hypoaesthesia | 90 | 5.4% | 1 | 23 |
| Nausea | 85 | 5.1% | 0 | 24 |
| Fall | 84 | 5.0% | 3 | 28 |
| Vision blurred | 81 | 4.8% | 0 | 13 |
| Muscular weakness | 77 | 4.6% | 2 | 28 |
| Malaise | 75 | 4.5% | 2 | 32 |
| Asthenia | 74 | 4.4% | 3 | 28 |
| Pain | 69 | 4.1% | 2 | 22 |
| Back pain | 65 | 3.9% | 0 | 15 |
| Dyspnoea | 65 | 3.9% | 1 | 14 |
| White blood cell count decreased | 65 | 3.9% | 1 | 11 |
| Visual impairment | 64 | 3.8% | 0 | 15 |
| Lymphocyte count decreased | 63 | 3.8% | 0 | 16 |
| Pain in extremity | 61 | 3.7% | 0 | 17 |
Who Reports GILENYA Side Effects? Age & Gender Data
Average age: 44.3 years. Most reports from: US. View detailed demographics →
Is GILENYA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2010 | 5 | 0 | 0 |
| 2011 | 93 | 4 | 10 |
| 2012 | 191 | 1 | 26 |
| 2013 | 442 | 15 | 138 |
| 2014 | 365 | 9 | 141 |
What Is GILENYA Used For?
| Indication | Reports |
|---|---|
| Multiple sclerosis | 1,114 |
| Relapsing-remitting multiple sclerosis | 256 |
| Product used for unknown indication | 18 |
| Multiple sclerosis relapse | 6 |
| Off label use | 6 |
GILENYA vs Alternatives: Which Is Safer?
GILENYA vs GILOTRIF
GILENYA vs GILTERITINIB
GILENYA vs GIMERACIL\OTERACIL\TEGAFUR
GILENYA vs GINKGO
GILENYA vs GIVINOSTAT
GILENYA vs GIVOSIRAN
GILENYA vs GLASDEGIB
GILENYA vs GLATIRAMER
GILENYA vs GLECAPREVIR\PIBRENTASVIR
GILENYA vs GLEEVEC
Official FDA Label for GILENYA
Official prescribing information from the FDA-approved drug label.